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Abstract Purpose Annually, the French Ministry of Health funds clinical research projects based on a national call for projects. Since 2013, the Ministry has prioritized funding of primary care. Projects selected for funding are made public without distinguishing the specific area of research. The objective of this study was to identify and describe the evolution of the primary care research projects funded by the Ministry of Health between 2013 and 2019. Method We reviewed all of the 1796 medical research projects funded between 2013 and 2019 and categorized projects as primary care projects by using a list of specific keywords. This list was established through two approaches: (1) selected by an expert committee, the RECaP primary care working group, and (2) using an automated textual analysis of published articles in the field. The keywords were used to screen the titles of the medical research projects funded. The abstracts (at www.clinicaltrials.gov ) or details (from project leaders) were then analyzed by two independent reviewers to determine true primary care projects. Results Finally, 49 primary care projects were identified, representing 2.7% of all medical research projects funded, without any significant change over the period. These projects were predominantly interventional (69%), with a median number of patients expected per project of 902. Conclusion Despite the prioritization of primary care research in 2013 by the French ministry of health, the number and proportion of projects funded remains low, with no significant change over the years. Trial registration Not applicable.

Abstract Background If any benefit is to be derived from the use of the health-related quality of life (HRQoL) questionnaires in chronic kidney disease (CKD) patients, they should be validated and culturally adapted to the target population. We aimed to critically appraise the psychometric properties of HRQoL questionnaires used in African populations with CKD. Methods Web of Science, Embase, PubMed and PsycINFO databases were searched. Psychometric validation studies of HRQoL questionnaires reporting at least one psychometric property of the COSMIN checklist in CKD African population, published up to October 16, 2023 were included and independently assessed for methodological quality and level of measurement properties by using the COSMIN methodology. Results From 1163 articles, 5 full-text were included. Only the Kidney Disease Quality-of-Life questionnaire was translated and cross-culturally adapted for studies of patients with CKD. Internal consistency was of doubtful quality in 4 studies and very good in 1. Its measurement was sufficient in 1 study and insufficient in 4. Test–retest reliability was of doubtful quality in 4 studies. Its measurement was sufficient in 3 studies and insufficient in 1. Structural validity was of inadequate quality in 1 study and very good quality in 1. Its measurement was sufficient in both. Construct validity was of inadequate quality in all studies. Their measurement was insufficient in 4 studies and sufficient in 1. Conclusions This review highlighted that only one HRQoL questionnaire used in studies of African populations with CKD underwent a small number of cultural adaptations and psychometric validations, generally of poor methodological quality. HRQoL validation studies in African CKD populations are needed to better take advantage of the benefits in patient care, population health management, and research.

Abstract Administrative databases are an alternative to disease registries as a research tool to study multiple sclerosis. However, they are not initially designed to fulfill research purposes. Therefore, an evaluation of their performance is necessary. Our objective was to assess the performance of the French administrative database comprising hospital discharge records and national health insurance databases in identifying individuals with multiple sclerosis, in comparison with a registry that exhaustively compiles resident multiple sclerosis cases in Lorraine, northeastern France, as reference. We recorded all individuals residing in the Lorraine region who were identified by the administrative database or the registry as having multiple sclerosis from 2011 to 2016. We calculated the Matthews correlation coefficient and other concordance indicators. For identifying individuals with multiple sclerosis, the Matthews correlation coefficient by the administrative database was 0.79 (95% CI 0.78–0.80), reflecting moderate performance. The mean time to identification was 5.5 years earlier with the registry than the administrative database. Administrative databases, although useful to study multiple sclerosis, should be used with caution because results of studies based on them may be biased. Our study highlights the value of regional registries that allow for a more exhaustive and rapid identification of cases.

Background The optimal management of patients with symptomatic isolated internal carotid artery (ICA) occlusion is unknown. We aimed to assess whether endovascular treatment (EVT) compared with standard medical care was associated with improved functional outcomes in patients with acute symptomatic isolated intracranial ICA occlusion without involvement of the middle or anterior cerebral artery, that is, ICA‐I occlusion. Additionally, we aimed to compare ICA‐I with ICA‐L/T occlusion, which involves themiddle and anterior cerebral artery, respectively. Methods We analyzed data from the highly effective reperfusion evaluated in multiple endovascular stroke trials (HERMES) collaboration, which performed an individual patient data meta‐analysis of 7 randomized controlled trials conducted between 2010 and 2017 assessing the benefit of EVT compared to medical management in patients with anterior circulation large vessel occlusion. We assessed the association between EVT and 90‐day good functional outcome (modified Rankin scale scores 0–2), National Institutes of Health Stroke Scale scores at 24 hours, symptomatic intracranial hemorrhage rates and mortality in patients with ICA‐I and ICA‐L/T occlusion. Results We included 442 patients with intracranial ICA occlusion, of whom 38 (8.6%) had ICA‐I occlusion. In the ICA‐I group, the median age [interquartile range] was 69.5 [61.7–79.5] years, 42.1% were male, and median baseline National Institutes of Health Stroke Scale was 17 [15–20]. Compared with standard medical care alone, EVT resulted in higher good outcome rates in patients with ICA‐I (42.9% versus 25%; P=0.296) and ICA‐L/T occlusion (32.5% versus 14.4%; P

Abstract Background The Inventory of Parental Representations (IPR), a self-administered questionnaire, was developed primarily to identify styles of attachment in adolescence. However, it did not present stable psychometric properties in the various American studies carried out. The aim of this study was to adapt the IPR in French and to provide a shorter version with improved psychometric properties and sound content. Methods The cross-cultural adaptation and content validity were carried out based on qualitative analysis by an Expert Committee and 10 non-clinical adolescents. For the quantitative analyses a cohort of 535 adolescent volunteers was enrolled, corresponding to 1070 responses, and divided into two groups: development and validation. The study of the metric properties of the adapted version of the IPR was realized in the development group, a sample of 275 responses. In case of mediocre results in the Confirmatory Factor Analysis, the development of a new and reduced IPR structure was planned using a mixed method including Classical Test Theory and Rasch Modelling in the development group. Subsequently, the study of the psychometric properties of the short, adapted version was confirmed in an independent sample of 795 responses (validation group). Results Out of 62 items translated, 13 needed adaptations. The analysis of their metric properties produced mediocre results. Content and psychometric property analyses generated two Short version of the IPR in the development group: a paternal scale for Fathers (Short IPRF) with 15 items and a maternal scale for Mothers (Short IPRM) with 16 items. The sound content and good psychometric properties were confirmed in the validation group (Short IPRF: Comparative Fit Index = 0.987, Tucker-Lewis Index = 0.982, Root Mean Square Error of Approximation = 0.027; Short IPRM: Comparative Fit Index = 0.953, Trucker-Lewis Index = 0.927, Root Mean Square Error of Approximation = 0.068). Using Rasch modelling, the attachment was correctly measured overall especially for insecure attachment. Conclusions A step-by-step process involving led to the generation of two questionnaires: a paternal scale, the Short IPRF, and a maternal scale with the Short IPRM providing opportunities to use this self-questionnaire to assess attachment among adolescents. Further work will provide a solid rating for this new tool.

Abstract Objective: To investigate clustering of risk behaviours in adolescents with excess weight. Design: Cross-sectional analysis of baseline data from the PRALIMAP-INÈS trial. Information on food frequency consumption (fruit, vegetables, sugary products and beverages), physical activity, sedentary behaviour (week and weekend days), smoking and alcohol consumption (current frequency and intoxication episodes) and socio-demographic data was collected using self-reported questionnaires. Behavioural risk factors were entered as categorical variables in a two-step clustering procedure: multiple correspondence analysis followed by hierarchical clustering. Associations between cluster membership and socio-demographic variables were investigated using multivariable multinomial logistic regression. Setting: French PRALIMAP-INÈS trial. Participants: Adolescents with excess weight. Results: A total of 1391 participants (13–18 years old, 58·2 % female) were included in the analysis, which resulted in the identification of four groups of participants, including, respectively, 543 (39·0 %), 373 (26·8 %), 246 (17·7 %) and 229 (16·5 %) participants. Clusters 1 and 4 showed associations of rather healthy behaviours (high physical activity and low consumption of sugary products; high consumption of fruit and vegetables, respectively), while clusters 2 and 3 showed associations of rather unhealthy behaviours (high sedentary behaviour and low consumption of fruit and vegetables; smoking and alcohol consumption, respectively). Both social status and family structure were associated with cluster membership. Conclusions: Risk behaviour patterns in adolescents with excess weight were clustered in both healthier and less healthy ways, with a complex interplay with socio-demographic factors.

Lifestyle factors (such as diet, physical activity or smoking habits, among others) are known to influence the progression of rheumatic and musculoskeletal diseases (RMDs). Despite contemporary improvements in RMD care, the management of lifestyle factors is suboptimal. In the context of a recent European Alliance of Associations for Rheumatology (EULAR) task force, existing informative materials regarding lifestyle factors for people with RMDs were collected from national organisations across European countries. Current materials show important limitations in terms of coverage, literature support and access, which may make the implementation of successful interventions difficult. In the present viewpoint, a roadmap to cover these gaps at the European level with the recent EULAR recommendations on lifestyle factors is discussed from an implementation perspective. This analysis may pave the ground for future implementation endeavours at the European level related to non-pharmacological interventions that may also be applicable beyond rheumatology.

Introduction: Since the COVID-19, changes have occurred for the Moroccan medical students, which represent a vulnerable population. Coping with this situation could be difficult. Our objective was to estimate and understand the psychosocial barriers to the medical students’ well-being at the Faculty of Medicine and Pharmacy of Marrakesh (FMPM) by evaluating their coping strategies, difficulties and needs.Methods: We conducted a mixed method study among pregraduate medical students. For the quantitative part, we did a cross-sectional study using an online four-part self-administeredquestionnaire. We compared Likert scales of perceived wellbeing before and one year after the lockdown. The scales ranged from 0 (very low state of well-being) to 10 (complete state ofwell-being). Coping strategies were assessed by the Brief-COPE questionnaire. The qualitative perspective was a case-study with semi-structured interviews using an interview guide based onthe literature review. Finally, a one-phase triangulation analysis, underlined by a convergence model, was done.Results: We had 355 participants for the quantitative part (participation rate of 16.6%). The mean age was 19.2±1.6. The female/male sex ratio was 1.8. The first cycle students represented 76%. The well-being mean state was better before than after the pandemic (7.8 vs 5.4; P

Abstract Multiple sclerosis (MS) is a neurodegenerative disease of the central nervous system. An increase in MS incidence over time is reported in several regions of the world. We aimed to describe the evolution of the annual MS incidence in the Lorraine region, France, from 1996 to 2015 and to analyze potential components of a possible change by a temporal effect of age at MS onset, MS onset period, and birth cohort, overall and for each sex. Cases were identified from ReLSEP, a population-based registry of MS cases living in Lorraine, northeastern France, with MS onset between 1996 and 2015. Age-period-cohort modeling was used to describe trends in MS incidence. Annual age- and sex-standardized incidences were relatively stable: 6.76/100 000 population (95%CI [5.76–7.91]) in 1996 and 6.78/100 000 (95%CI [5.72–7.97]) in 2015. The incidence ratio between women and men was 2.4. For all time periods, the peak incidence occurred between ages 25 and 35 years. Age-period–adjusted cohort and age-cohort–adjusted period analyses did not reveal a period or cohort effect. The incidence of MS remained stable over the study period in Lorraine, and we could not identify any particular effect of disease onset period or birth period on this evolution.

Abstract Background The COVID-19 epidemic has sent students around the world in to lockdown. This study sought to assess the prevalence of impaired self-perceived mental health and identify associated factors among French post-secondary students during the lockdown. Methods A cross-sectional study was conducted among French students living in the Grand Est area in France from May 7 to 17, 2020 during the first lockdown. An online survey was used to collect sociodemographic data, learning and teaching conditions, living conditions, and exposure to COVID-19, and self-perceived mental health was assessed with mental composite score (MCS) of the SF-12. Results Overall, 4018 were analyzed. Most participants were female (70.7%), and the mean age was 21.7 years (SD 4.0). The mean MCS score was 44.5 (SD 17.3). Impaired mental health, defined by a MCS

Public authorities and academics have advocated for applying been advocating for the application of the setting-based approach to sports clubs. However, studies have shown that existing health promotion (HP) interventions in sports clubs poorly understand and apply this approach. Moreover, methods used to evaluate these interventions do not inform their implementation process, limiting the generation effectiveness’ proofs. This study aims at evaluating the implementation process and effectiveness of an HP intervention in sports clubs (PROmotion de la Santé dans les ClubS de Spor; PROSCeSS), based on the health-promoting sports club (HPSC) model.A type 3 hybrid design, using a multiphase mixed-method: QUAN→QUAL→ QUAN+QUAL (qual)→QUAL (quan+qual), will be used. Phase A will be a pre–post–quantitative study with one HP officer, five managers and five coaches from 30 sports clubs exploring the effects of the PROSCeSS intervention on HP perceptions and health literacy. Phase B will be focus groups with participants from HP initiatives that the 30 sports clubs will have previously put in place to detect changes in health. Phase C will explain the results of phases A and B by choice of strategies and adherence to standardised steps, measured through semistructured interviews and implementation data collection. Phase D will cross-reference the semistructured interviews, the sports club characteristics questionnaire and the implementation data collection to study the relationships between the context and the implementation process. This protocol will identify ‘what works’, ‘for whom’, in ‘what context’ in terms of HPSC and clarify which intervention components are more effective at improving HP. This evaluation design will help to develop appropriate approaches to evaluate HP interventions.

Objectives Around 30% of patients with rheumatoid arthritis (RA) do not respond to tumour necrosis factor inhibitors (TNFi). We aimed to predict patient response to TNFi using machine learning on simple clinical and biological data.Methods We used data from the RA ESPOIR cohort to train our models. The endpoints were the EULAR response and the change in Disease Activity Score (DAS28). We compared the performances of multiple models (linear regression, random forest, XGBoost and CatBoost) on the training set and cross-validated them using the area under the receiver operating characteristic curve (AUROC) or the mean squared error. The best model was then evaluated on a replication cohort (ABIRISK).Results We included 161 patients from ESPOIR and 118 patients from ABIRISK. The key selected features were DAS28, lymphocytes, ALT (aspartate aminotransferase), neutrophils, age, weight, and smoking status. When predicting EULAR response, CatBoost achieved the best performances of the four tested models. It reached an AUROC of 0.72 (0.68–0.73) on the train set (ESPOIR). Better results were obtained on the train set when etanercept and monoclonal antibodies were analysed separately. On the test set (ABIRISK), these models respectively achieved on AUROC of 0.70 (0.57–0.82) and 0.71 (0.55–0.86). Two decision thresholds were tested. The first prioritised a high confidence in identifying responders and yielded a confidence up to 90% for predicting response. The second prioritised a high confidence in identifying inadequate responders and yielded a confidence up to 70% for predicting non-response. The change in DAS28 was predicted with an average error of 1.1 DAS28 points.Conclusion The machine learning models developed allowed predicting patient response to TNFi exclusively using data available in clinical routine.

Oxytocin (OT), a neuropeptide best known for its role in emotional and social behaviors, has been linked to osteoarthritis (OA). This study aimed to investigate the serum OT level in hip and/or knee OA patients and to study its association with disease progression. Patients from the KHOALA cohort with symptomatic hip and/or knee OA (Kellgren and Lawrence (KL) scores of 2 and 3) and follow-up at 5 years were included in this analysis. The primary endpoint was structural radiological progression, which was defined as an increase of at least one KL point at 5 years. Logistic regression models were used to estimate the associations between OT levels and KL progression while controlling for gender, age, BMI, diabetes and leptin levels. Data from 174 hip OA patients and 332 knee OA patients were analyzed independently. No differences in OT levels were found between the ‘progressors’ and ‘non-progressors’ groups among the hip OA patients and knee OA patients, respectively. No statistically significant associations were found between the OT levels at baseline and KL progression at 5 years, the KL score at baseline or the clinical outcomes. Higher structural damage at baseline and severe structural progression of hip and knee osteoarthritis did not appear to be associated with a low serum OT level at baseline.

Abstract Background Diagnosis performances of case-identifying algorithms developed in healthcare database are usually assessed by comparing identified cases with an external data source. When this is not feasible, intra-database validation can present an appropriate alternative. Objectives To illustrate through two practical examples how to perform intra-database validations of case-identifying algorithms using reconstituted Electronic Health Records (rEHRs). Methods Patients with 1) multiple sclerosis (MS) relapses and 2) metastatic castration-resistant prostate cancer (mCRPC) were identified in the French nationwide healthcare database (SNDS) using two case-identifying algorithms. A validation study was then conducted to estimate diagnostic performances of these algorithms through the calculation of their positive predictive value (PPV) and negative predictive value (NPV). To that end, anonymized rEHRs were generated based on the overall information captured in the SNDS over time (e.g. procedure, hospital stays, drug dispensing, medical visits) for a random selection of patients identified as cases or non-cases according to the predefined algorithms. For each disease, an independent validation committee reviewed the rEHRs of 100 cases and 100 non-cases in order to adjudicate on the status of the selected patients (true case/ true non-case), blinded with respect to the result of the corresponding algorithm. Results Algorithm for relapses identification in MS showed a 95% PPV and 100% NPV. Algorithm for mCRPC identification showed a 97% PPV and 99% NPV. Conclusion The use of rEHRs to conduct an intra-database validation appears to be a valuable tool to estimate the performances of a case-identifying algorithm and assess its validity, in the absence of alternative.

Introduction: Like other countries, France has invested in a national medical genomics program. Among the four pilot research studies, the DEFIDIAG project focuses on the use of whole genome sequencing (WGS) for patients with intellectual disability (ID), a neurodevelopmental condition affecting 1–3% of the general population but due to a plethora of genes. However, the access to genomic analyses has many potential individual and societal issues in addition to the technical challenges. In order to help decision-makers optimally introduce genomic testing in France, there is a need to identify the socio-economic obstacles and leverages associated with the implementation of WGS.Methods and Analysis: This humanities and social sciences analysis is part of the DEFIDIAG study. The main goal of DEFIDIAG is to compare the percentage of causal genetic diagnoses obtained by trio WGS (including the patient and both parents) (WGST) to the percentage obtained using the minimal reference strategy currently used in France (Fragile-X testing, chromosomal microarray analysis, and gene panel strategy including 44 ID genes) for patients with ID having their first clinical genetics consultation. Additionally, four complementary studies will be conducted. First, a cost-effectiveness analysis will be undertaken in a subsample of 196 patients consulting for the first time for a genetic evaluation; in a blinded fashion, WGST and solo (index case, only) genomic analysis (WGSS) will be compared to the reference strategy. In addition, quantitative studies will be conducted: the first will estimate the cost of the diagnostic odyssey that could potentially be avoidable with first-line WGST in all patients previously investigated in the DEFIDIAG study; the second will estimate changes in follow-up of the patients in the year after the return of the WGST analysis compared to the period before inclusion. Finally, through semi-directive interviews, we will explore the expectations of 60 parents regarding genomic analyses.Discussion: Humanities and social sciences studies can be used to demonstrate the efficiency of WGS and assess the value that families associate with sequencing. These studies are thus expected to clarify trade-offs and to help optimize the implementation of genomic sequencing in France.Ethics Statement: The protocol was approved by the Ethics Committee Sud Méditerranée I (June 2019)—identification number: 2018-A00680-55 and the French data privacy commission (CNIL, authorization 919361).Clinical Trial Registration: (ClinicalTrials.gov), identifier (NCT04154891).

Introduction: Intellectual Disability (ID) is the most common cause of referral to pediatric genetic centers, as it affects around 1–3% of the general population and is characterized by a wide genetic heterogeneity. The Genome Sequencing (GS) approach is expected to achieve a higher diagnostic yield than exome sequencing given its wider and more homogenous coverage, and, since theoretically, it can more accurately detect variations in regions traditionally not well captured and identify structural variants, or intergenic/deep intronic putatively pathological events. The decreasing cost of sequencing, the progress in data-management and bioinformatics, prompted us to assess GS efficiency as the first line procedure to identify the molecular diagnosis in patients without obvious ID etiology. This work is being carried out in the framework of the national French initiative for genomic medicine (Plan France Médecine Génomique 2025).Methods and Analysis: This multidisciplinary, prospective diagnostic study will compare the diagnostic yield of GS trio analysis (index case, father, mother) with the French core minimal reference strategy (Fragile-X testing, chromosomal microarray analysis and Gene Panel Strategy of 44 selected ID genes). Both strategies are applied in a blinded fashion, in parallel, in the same population of 1275 ID index cases with no obvious diagnosis (50% not previously investigated). Among them, a subgroup of 196 patients are randomized to undergo GS proband analysis in addition to GS trio analysis plus the French core minimal reference strategy, in order to compare their efficiency. The study also aims to identify the most appropriate strategy according to the clinical presentation of the patients, to evaluate the impact of deployment of GS on the families’ diagnostic odyssey and the modification of their care, and to identify the advantages/difficulties for the patients and their families.Ethics Statement: The protocol was approved by the Ethics Committee Sud Méditerranée I and the French data privacy commission (CNIL, authorization 919361).Trial Registration:ClinicalTrials.gov identifier NCT04154891 (07/11/2019).

BackgroundSeveral countries have implemented mobile apps in an attempt to trace close contacts of patients with COVID-19 and, in turn, reduce the spread of SARS-CoV-2. However, the effectiveness of this approach depends on the adherence of a large segment of the population. ObjectiveThe aims of this study were to evaluate the acceptability of a COVID-19 contact tracing mobile app among the French population and to investigate the barriers to its use. MethodsThe Health Literacy Survey 2019 questioned 1003 people in France during the COVID-19 pandemic on the basis of quota sampling. The survey collected sociodemographic characteristics and health literacy data, as well as information on participants’ communication with caregivers, trust in institutions, and COVID-19 knowledge and preventive behaviors. The acceptability of a mobile app for contact tracing was measured by a single question, the responses to which were grouped into three modalities: app-supporting, app-willing, and app-reluctant. Multinomial logistic regression analysis was performed to identify the factors associated with the acceptability of a mobile app during the COVID-19 pandemic. ResultsOnly 19.2% (193/1003) of all participants were app-supporting, whereas half of them (504/1003, 50.3%) were reluctant. The factors associated with willingness or support toward the contact tracing app included lower financial deprivation (app-willing: adjusted odds ratio [aOR] 0.8, 95% CI 0.69-0.93; app-supporting: aOR 0.7, 95% CI 0.58-0.84) and higher perceived usefulness of using a mobile app to send completed health questionnaires to doctors (app-willing: aOR 2.3, 95% CI 1.70-3.26; app-supporting: aOR 3.1, 95% CI 2.04-4.82). Furthermore, the likelihood of supporting the mobile app increased with age over 60 years (aOR 1.9, 95% CI 1.13-3.22), trust in political representatives (aOR 2.7, 95% CI 1.72-4.23), feeling concerned about the pandemic situation (aOR 2.2, 95% CI 1.47-3.32), and knowledge about the transmission of COVID-19 (aOR 2.0, 95% CI 1.39-2.96). ConclusionsThe most socioeconomically precarious people, who are at a higher risk of SARS-CoV-2 infection, are also the most reluctant to using a contact tracing mobile app. Therefore, optimal adherence can only be effective with a targeted discourse on public health benefits to adopt such an app, which should be combined with a reduction in inequalities by acting on structural determinants.

Abstract Introduction Health-related quality of life (HRQoL) is a priority for patients. The objectives were to describe the changes in HRQoL over 5–8 years in patients with early arthritis (EA) or early inflammatory back pain (IBP) and to explore factors associated to HRQoL. Patients and methods In 2 prospective observational French cohorts (ESPOIR for EA patients and DESIR for early IBP patients), HRQoL was assessed regularly over 5–8 years, using the SF36 physical and mental composite scores (PCS and MCS, range 0–100). Disease activity was assessed by DAS28-ESR and ASDAS-CRP. Univariate and multivariate linear mixed-effect models and trajectory-based mapping were applied. Results In all, 1347 patients (701 EA and 646 early IBP) were analysed: mean age 48.4 ± 12.2 and 33.9 ± 8.7 years respectively; mean disease duration 3.4 ± 1.7 and 18.2 ± 10.8 months; and 76.3% and 55.0% females. At baseline, in EA, mean PCS and MCS were respectively 40.2 ± 9.1 and 40.4 ± 11.2 and, in early IBP, were respectively 38.5 ± 8.5 and 39.8 ± 10.9. Over follow-up, HRQoL mean levels improved mostly over the first 6 months (p

Infarct volume (FIV) on follow-up diffusion-weighted imaging (FU-DWI) is only moderately associated with functional outcome in acute ischemic stroke patients. However, FU-DWI may contain other imaging biomarkers that could aid in improving outcome prediction models for acute ischemic stroke. We included FU-DWI data from the HERMES, ISLES, and MR CLEAN-NO IV databases. Lesions were segmented using a deep learning model trained on the HERMES and ISLES datasets. We assessed the performance of three classifiers in predicting functional independence for the MR CLEAN-NO IV trial cohort based on: (1) FIV alone, (2) the most important features obtained from a trained convolutional autoencoder (CAE), and (3) radiomics. Furthermore, we investigated feature importance in the radiomic-feature-based model. For outcome prediction, we included 206 patients: 144 scans were included in the training set, 21 in the validation set, and 41 in the test set. The classifiers that included the CAE and the radiomic features showed AUC values of 0.88 and 0.81, respectively, while the model based on FIV had an AUC of 0.79. This difference was not found to be statistically significant. Feature importance results showed that lesion intensity heterogeneity received more weight than lesion volume in outcome prediction. This study suggests that predictions of functional outcome should not be based on FIV alone and that FU-DWI images capture additional prognostic information.

Objectives: Little information is available on the characteristics of elderly patients starting TNFα antagonist treatment for rheumatoid arthritis (RA). The objective of this work was to compare prescription patterns in RA patients younger vs. older than 75 years. Methods: Biologic-naive patients with active RA (DAS28 > 3.2) despite first-line therapy were included between 2007 and 2009 in the prospective, multicentre, longitudinal, observational, population-based CORPUS-RA cohort. TNFα antagonist users were defined as having received at least one TNFα antagonist during the first study year. The groups

Background: At least 17% of the population suffers from osteoarthritis (OA) in Hungary, according to the European Health Interview Survey. In Hungary, until now there was no OA-specific questionnaire available for the lower limb, in order to monitor the health-related quality of life (HRQoL). This gap gave the relevance of this research. The aim of the study was to perform the Hungarian cross-cultural adaptation and validation of the French-developed Osteoarthritis Knee and Hip Quality of Life (OAKHQoL) questionnaire. Methods: The five-step translation procedure of the original OAKHQoL was performed by the expert panel and the translators. The created Hungarian version (OAKHQoL-HUN) was tested in six different geographical areas of Hungary. The validity and the reliability of this adapted tool was analyzed by our research group. Results: A total of 99 patients completed the questionnaires (78 women and 21 men), with the average age of 66.6 years (standard deviation (SD) 12.1), living with OA for more than 10 years. Excellent internal consistency was observed in the following domains: physical activity (α = 0.93), mental health (α = 0.91) and pain (α = 0.89). Good correlation was determined between physical subscales ( r = 0.615–0.676) and mental subscales ( r = 0.633–0.643) compared to generic quality of life instruments (World Health Organization Quality of life – BREF questionnaire and EQ-5D-3L). Conclusion: The OAKHQoL-HUN is the first valid and reliable tool for measuring the Hungarian lower limb OA patients’ quality of life. Trial Registration: This study is registered (24950-3/2016/EKU) by the National Ethics Committee: the Hungarian Medical Research Council.

Pretreatment ischemic location may be an important determinant for functional outcome prediction in acute ischemic stroke. In total, 143 anterior circulation ischemic stroke patients in the THRACE study were included. Ischemic lesions were semi-automatically segmented on pretreatment diffusion-weighted imaging and registered on brain atlases. The percentage of ischemic tissue in each atlas-segmented region was calculated. Statistical models with logistic regression and support vector machine were built to analyze the predictors of functional outcome. The investigated parameters included: age, baseline National Institutes of Health Stroke Scale score, and lesional volume (three-parameter model), together with the ischemic percentage in each atlas-segmented region (four-parameter model). The support vector machine with radial basis functions outperformed logistic regression in prediction accuracy. The support vector machine three-parameter model demonstrated an area under the curve of 0.77, while the four-parameter model achieved a higher area under the curve (0.82). Regions with marked impacts on outcome prediction were the uncinate fasciculus, postcentral gyrus, putamen, middle occipital gyrus, supramarginal gyrus, and posterior corona radiata in the left hemisphere; and the uncinate fasciculus, paracentral lobule, temporal pole, hippocampus, inferior occipital gyrus, middle temporal gyrus, pallidum, and anterior limb of the internal capsule in the right hemisphere. In conclusion, pretreatment ischemic location provided significant prognostic information for functional outcome in ischemic stroke.

The World Health Organisation recommends monitoring the circulation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We investigated anti–SARS-CoV-2 total immunoglobulin (IgT) antibody seroprevalence and in vitro sero-neutralization in Nancy, France, in spring 2020. Individuals were randomly sampled from electoral lists and invited with household members over 5 years old to be tested for anti–SARS-CoV-2 (IgT, i.e., IgA/IgG/IgM) antibodies by ELISA (Bio-rad); the sero-neutralization activity was evaluated on Vero CCL-81 cells. Among 2006 individuals, the raw seroprevalence was 2.1% (95% confidence interval 1.5 to 2.9), was highest for 20- to 34-year-old participants (4.7% (2.3 to 8.4)), within than out of socially deprived area (2.5% vs. 1%, p = 0.02) and with than without intra-family infection (p < 10−6). Moreover, 25% of participants presented at least one COVID-19 symptom associated with SARS-CoV-2 positivity (p < 10−13), with highly discriminant anosmia or ageusia (odds ratio 27.8 [13.9 to 54.5]); 16.3% (6.8 to 30.7) of seropositive individuals were asymptomatic. Positive sero-neutralization was demonstrated in vitro for 31/43 seropositive subjects. Regarding the very low seroprevalence, a preventive effect of the lockdown in March 2020 can be assumed for the summer, but a second COVID-19 wave, as expected, could be subsequently observed in this poorly immunized population.

The incidence of multiple sclerosis (MS) changes from generation to generation in ethnically different immigrants compared with native-born people. We aimed to determine whether there are generational changes in MS phenotypes among North African immigrants in France.Cohort study with data from a population-based MS registry to compare the clinical characteristics of 80 first (NAG1) and 167 second (NAG2) generation North Africans with MS living in France with 5200 native-born Europeans. Adjusted Cox models were used to test the association between scores of 3 and 6 on the expanded disability status scale (EDSS) and the "origin/generation" variable.Cox models for EDSS scores 3 and 6 showed a higher risk of score 3 (hazard ratio = 1.738, 95% confidence interval 1.237 to 2.444; P = .002) and 6 (hazard ratio = 2.372, 95% confidence interval 1.626 to 3.462; P

INTRODUCTION:Geographical variation in the prevalence of multiple sclerosis (MS) is controversial. Heterogeneity is important to acknowledge to adapt the provision of care within the healthcare system. We aimed to investigate differences in prevalence of MS in departments in the French territory. METHODS:We estimated MS prevalence on October 31, 2004 in 21 administrative departments in France (22% of the metropolitan departments) by using multiple data sources: the main French health insurance systems, neurologist networks devoted to MS and the Technical Information Agency of Hospitalization. We used a spatial Bayesian approach based on estimating the number of MS cases from 2005 and 2008 capture-recapture studies to analyze differences in prevalence. RESULTS:The age- and sex-standardized prevalence of MS per 100,000 inhabitants ranged from 68.1 (95% credible interval 54.6, 84.4) in Hautes-Pyrénées (southwest France) to 296.5 (258.8, 338.9) in Moselle (northeast France). The greatest prevalence was in the northeast departments, and the other departments showed great variability. DISCUSSION:By combining multiple data sources into a spatial Bayesian model, we found heterogeneity in MS prevalence among the 21 departments of France, some with higher prevalence than anticipated from previous publications. No clear explanation related to health insurance coverage and hospital facilities can be advanced. Population migration, socioeconomic status of the population studied and environmental effects are suspected.

OBJECTIVES: To estimate annual direct costs of early RA by resource component in an inception cohort, with reference to four distinct treatment strategies: no disease modifying antirheumatic drugs (DMARDs), synthetic DMARDs only, biologic DMARDs in the first year ('first-year biologic', FYB), and biologic DMARDs from the second year after inclusion ('later-year biologic', LYB); to determine predictors of total and non-DMARD related costs. METHODS: The ESPOIR cohort is a French multicentric, prospective study of 813 patients with early arthritis. Data assessing RA-related resource utilisation and disease characteristics were collected at baseline, biannually during the first two years and annually thereafter. Costs predictors were determined by generalised linear mixed analyses. RESULTS: Over the 4-year follow-up, mean annual direct total costs per treatment strategy group were €3,612 for all patients and €998, €1,922, €14,791, €8,477 respectively for no DMARDs, synthetic DMARDs only, FYB and LYB users. The main predictors of higher costs were biologic use and higher Health Assessment Questionnaire (HAQ) scores at baseline. Being a biologic user led to a higher total cost (FYB Rate Ratio (RR) 7.22, [95% CI 5.59-9.31]; LYB RR 4.39, [95% CI 3.58-5.39]) compared to non-biologic users. Only LYB increased non-DMARD related costs compared to all other patients by 60%. CONCLUSIONS: FYB users incurred the highest levels of total costs, while their non-DMARD related costs remained similar to non-biologic users, possibly reflecting better RA control.

BACKGROUND: This prospective multicenter study aimed to study the impact of the recalibration component of response-shift (RS) on time to deterioration (TTD) in health related quality of life (QoL) scores in breast cancer (BC) patients and the influence of baseline QoL expectations on TTD. METHODS: The EORTC-QLQ-C30 and BR-23 questionnaires were used to assess the QoL in a prospective multicenter study at inclusion (T0), at the end of the first hospitalization (T1) and, three (T2) and 6 months after the first hospitalization (T3). Recalibration was investigated by the then-test method. QoL expectancy was assessed at diagnosis. Deterioration was defined as a 5-point decrease in QoL scores, considered a minimal clinically important difference (MCID). TTD was estimated using the Kaplan-Meier method. Cox regression analyses were used to identify factors influencing TTD. RESULTS: From February 2006 to February 2008, 381 women were included. Recalibration of breast cancer patients' internal standards in the assessment of their QoL had an impact on TTD. Median TTD were significantly shorter when recalibration was not taken into account than when recalibration was taken into account for global health, role-functioning, social-functioning, body-image and side effects of systemic therapy. Cox multivariate analyses showed that for body image, when recalibration was taken into account, radiotherapy was associated with a shorter TTD (HR: 0.60[0.38-0.94], whereas, no significant impact of surgery type on TTD was observed. For global health, cognitive and social functioning dimensions, patients expecting a deterioration in their QoL at baseline had a significantly shorter TTD. CONCLUSIONS: Our results showed that RS and baseline QoL expectations were associated with time to deterioration in breast cancer patients.

BACKGROUND: Patient-reported outcomes (PRO) that comprise all self-reported measures by the patient are important as endpoint in clinical trials and epidemiological studies. Models from the Item Response Theory (IRT) are increasingly used to analyze these particular outcomes that bring into play a latent variable as these outcomes cannot be directly observed. Preliminary developments have been proposed for sample size and power determination for the comparison of PRO in cross-sectional studies comparing two groups of patients when an IRT model is intended to be used for analysis. The objective of this work was to validate these developments in a large number of situations reflecting real-life studies. METHODOLOGY: The method to determine the power relies on the characteristics of the latent trait and of the questionnaire (distribution of the items), the difference between the latent variable mean in each group and the variance of this difference estimated using Cramer-Rao bound. Different scenarios were considered to evaluate the impact of the characteristics of the questionnaire and of the variance of the latent trait on performances of the Cramer-Rao method. The power obtained using Cramer-Rao method was compared to simulations. PRINCIPAL FINDINGS: Powers achieved with the Cramer-Rao method were close to powers obtained from simulations when the questionnaire was suitable for the studied population. Nevertheless, we have shown an underestimation of power with the Cramer-Rao method when the questionnaire was less suitable for the population. Besides, the Cramer-Rao method stays valid whatever the values of the variance of the latent trait. CONCLUSIONS: The Cramer-Rao method is adequate to determine the power of a test of group effect at design stage for two-group comparison studies including patient-reported outcomes in health sciences. At the design stage, the questionnaire used to measure the intended PRO should be carefully chosen in relation to the studied population.

Background For patients with stroke with large-vessel occlusion (LVO), study of factors predicting response to intravenous thrombolysis (IVT) would allow identifying subgroups with high expected gain, and those for whom it could be considered as futile, and even detrimental. From patients included in the Mechanical Thrombectomy After Intravenous Alteplase vs Alteplase Alone After Stroke trial, we investigated clinical-imaging factors associated with optimal response to IVT.Methods We included patients receiving IVT alone. Excellent outcome was defined by a 3-month modified Rankin Scale (mRS) score ≤1. Clinical-imaging predictors were assessed on multivariate analysis after multiple imputations. The predictive performance of the model was assessed with the C-statistic.Results Among 247 patients with LVO treated with IVT alone, 77 (31%) showed 3-month mRS ≤1. Predictors of 3-month mRS ≤1 were no medical history of hypertension (OR 2.43; 95% CI 1.74 to 3.38; p=0.007); no current smoking (OR 2.76; 95% CI 1.79 to 4.26; p=0.02); onset-to-IVT time (OR 0.47 per hour increase; 95% CI 0.23 to 0.78; p=0.003); diffusion-weighted imaging (DWI) volume (OR 0.78 per 10 mL increase; 95% CI 0.68 to 0.89; p=0.0004); presence of susceptibility vessel sign (SVS) (OR 7.89; 95% CI 1.65 to 37.78; p=0.01) and SVS length (OR 0.87 per mm increase; 95% CI 0.80 to 0.94; p=0.001). The prediction models showed a C-statistic=0.79 (95% CI 0.79 to 0.80).Conclusions In patients with stroke with anterior-circulation LVO treated with IVT alone, predictors of excellent outcome at 3 months were no medical history of hypertension or current smoking, reduced onset-to-IVT time, small DWI volume, presence of SVS and short SVS length. These predictive factors could help practitioners in decision-making for IVT implementation in reperfusion strategies, all the more for the drip and ship paradigm.Trial registration number NCT01062698.